Designs for left ventricular conduit

ABSTRACT

A conduit is provided to provide a bypass around a blockage in the coronary artery. The conduit is adapted to be positioned in the myocardium or heart wall to provide a passage for blood to flow between a chamber of the heart such as the left ventricle and the coronary artery, distal to the blockage. The stent is self-expanding or uses a balloon to expand the stent in the heart wall. Various attachment means are provided to anchor the stent and prevent its migration.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation application of U.S. patent application Ser. No.10/456,488, filed Jun. 9, 2003, now pending, which is a continuationapplication of U.S. patent application Ser. No. 09/829,449, filed Apr.10, 2001, now U.S. Pat. No. 6,610,100, which is a continuationapplication of U.S. patent application Ser. No. 09/369,048, filed Aug.4, 1999, now U.S. Pat. No. 6,290,728, and claims the benefits ofpriority of U.S. Provisional Patent Application No. 60/099,767, filedSep. 10, 1998, and U.S. Provisional Patent Application No. 60/104,397,filed Oct. 15, 1998, the entirety of all of which are incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates to an apparatus for bypassing a blockedblood vessel segment, and, more particularly, to a conduit or stentpositioned between the coronary artery or other blocked vessel and achamber of the heart, such as the left ventricle of the heart, to bypassa blocked segment of the coronary artery or other blood vessel.

BACKGROUND OF THE INVENTION

Coronary artery disease is a major problem in the U.S. and throughoutthe world. Coronary arteries as well as other blood vessels frequentlybecome clogged with plaque, which at the very least impairs theefficiency of the heart's pumping action, and can lead to heart attackand death. In some cases, these arteries can be unblocked throughnoninvasive techniques such as balloon angioplasty. In more difficultcases, a bypass of the blocked vessel is necessary.

In a bypass operation, one or more venous segments are inserted betweenthe aorta and the coronary artery. The inserted venous segments ortransplants act as a bypass of the blocked portion of the coronaryartery and thus provide for a free or unobstructed flow of blood to theheart. More than 500,000 bypass procedures are performed in the U.S.every year.

Such coronary artery bypass surgery, however, is a very intrusiveprocedure that is expensive, time-consuming and traumatic to thepatient. The operation requires an incision through the patient'ssternum (sternotomy), and that the patient be placed on a bypass pump sothat the heart can be operated on while not beating. A vein graft isharvested from the patient's leg, another highly invasive procedure, anda delicate surgical procedure is required to piece the bypass graft tothe coronary artery (anastomosis). Hospital stays subsequent to thesurgery and convalescence are prolonged.

As mentioned above, another conventional treatment is percutaneoustransluminal coronary angioplasty (PTCA) or other types of angioplasty.However, such vascular treatments are not always indicated due to thetype or location of the blockage, or due to the risk of emboli.

Thus, there is a need for an improved bypass system which is lesstraumatic to the patient.

SUMMARY OF THE INVENTION

The preferred embodiments of the present invention address the need inthe previous technology by providing a bypass system that avoids thesternotomy and other intrusive procedures normally associated withcoronary bypass surgery. These embodiments also free the surgeon fromthe multiple anastomoses necessary in the current process.

The preferred device provides a shunt for diverting blood directly froma chamber in the heart, such as the left ventricle, to the coronaryartery, distal to the blockage, therefore bypassing the blocked portionof the vessel. The shunt comprises a stent or conduit adapted to bepositioned in the heart wall or myocardium between the left ventricleand the coronary artery that allows for the direct passage of bloodtherethrough. As used herein, the terms “stent” and “conduit” areinterchangeable, and refer to a device that allows for the passage ofblood therethrough. The terms “myocardium” and “heart wall” are alsoused interchangeably. In addition, although the left ventricle isreferred to throughout the description, it should be understood that theconduit described herein can be used to provide a passageway for theflow of blood from any heart chamber, not only the left ventricle.

The stent device is delivered either externally or internally throughthe coronary artery to a position distal to the blockage. At thatposition, the coronary artery, the myocardium and the wall of the leftventricle are pierced to provide a channel completely through from thecoronary artery to the left ventricle of the heart. The stent is thenpositioned in the channel to provide a permanent passage for blood toflow between the left ventricle of the heart and the coronary artery,distal to the blockage. The stent is sized so that one open end ispositioned within the coronary artery, while the other open end ispositioned in the left ventricle. The hollow lumen of the stent providesa passage for the flow of blood.

The stent can be self-expandable or expanded by means of a balloon orsimilar device, and can be provided with various means to anchor it inposition within the myocardium, such as expandable legs, hooks, barbs,collars, suture holes and the like. The stent can be formed from aplurality of rings, which can be connected to provide stability. Thestent can include a valve in its interior, and can also be used todeliver drugs or other pharmaceutical compounds directly into themyocardium and the coronary circulation.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a cross-sectional view of a human heart, aorta and coronaryartery.

FIG. 1B is a side view of one embodiment of an expandable stent and theballoon catheter used for stent delivery.

FIG. 2 is a side view of the stent of FIG. 1B mounted on the distal endof the catheter for delivery into the myocardium, with the coronaryartery and myocardium shown cut-away.

FIG. 3 is a side view of the distal end of the stent/catheter assemblyof FIG. 1B positioned in the myocardium, with the coronary artery andmyocardium shown cut-away.

FIG. 4 is a cross-sectional side view of the stent of FIG. 1B positionedwithin the myocardium after removal of the catheter used for delivery.

FIG. 5 is a side view of another embodiment of the stent and thecatheter used for stent delivery.

FIG. 6 is a cross-sectional side view of the catheter and puncturedevice used to introduce the self-expanding stent of FIG. 5 into themyocardium.

FIG. 7 is a cross-sectional side view of the stent/catheter assembly ofFIG. 5 positioned in the myocardium.

FIG. 8 is a side view of the self-expanding stent of FIG. 5 positionedwithin the myocardium after removal of the catheter and puncture device,with the coronary artery and myocardium shown cut-away.

FIG. 9 is a perspective view of another embodiment of the stent havingexpandable legs, showing the stent mounted on the distal end of theintroducer catheter.

FIG. 10 is a perspective view of the stent of FIG. 9, showing the distalend of the introducer catheter pushed forward to allow the legs of thestent to expand.

FIG. 11 is a perspective view of the stent of FIG. 9, showing the legsof the stent in an expanded position.

FIG. 12 is a side view of another embodiment of the stent positionedwithin the myocardium, with the coronary artery and myocardium showncut-away.

FIG. 13 is a side view of a biodegradable stent positioned within themyocardium, with the coronary artery and myocardium shown cut-away.

FIG. 14 is a side view of a catheter and puncture device used tointroduce a bulkhead stent into the myocardium, with the coronary arteryand myocardium shown cut-away.

FIG. 15 is a side view of the stent/catheter assembly of FIG. 14positioned in the myocardium, with the coronary artery and myocardiumshown cutaway.

FIGS. 16-19 are progressive side views of the stent/catheter assembly ofFIG. 14, showing the bulkhead stent being deployed into the myocardium.

FIGS. 20 and 21 are enlarged views of FIGS. 18 and 19, respectively,showing the bulkhead stent being deployed into the myocardium.

FIG. 22 is a perspective view of a ring of a bulkhead stent in a loadedconfiguration

FIG. 23 is a perspective view of a ring of a bulkhead stent in aninserted configuration.

FIG. 24 is a perspective view of a bulkhead stent within a deliverycatheter, showing the rings of the bulkhead stent being inserted.

FIG. 25 is a perspective view of a bulkhead stent, with the rings of thestent in loaded and inserted configurations.

FIG. 26 is a perspective view of an inserter device used to insert abulkhead stent.

FIG. 27A is a schematic, cross-sectional view of the human heart,showing a catheter used to form a channel through the myocardium andinto the left ventricle inserted into the coronary artery.

FIG. 27B is an enlarged view of the distal end of the catheter and thechannel through the myocardium in FIG. 27A.

FIG. 28 is a schematic, cross-sectional view of a stent deliverycatheter positioned inside the channel formed in the myocardium.

FIG. 29 is a schematic, partial cross-sectional view of a self-expandingspring stent being positioned in the channel formed in the myocardium.

FIG. 30 is a schematic, partial cross-sectional view of theself-expanding stent deployed within the myocardium.

FIG. 31 is a perspective view of another embodiment of a stent havingretention members which maintain the position of the stent.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

As is well known, the coronary artery branches off the aorta and ispositioned along the external surface of the heart wall. The anatomy ofthe human heart is illustrated in FIG. 1A. Oxygenated blood flows fromthe heart PH to the aorta AO, on to the rest of the body, some of theblood flowing into the coronary artery CA. In some individuals, plaquebuilds up within the coronary artery CA, blocking the free flow of bloodand causing complications ranging from mild angina to heart attack anddeath.

In order to restore the flow of oxygenated blood through the coronaryartery, one embodiment of the present invention provides for theshunting of blood directly from the heart to a site in the coronaryartery that is distal to the blockage. A channel is formed through thewall of the coronary artery and the myocardium and into the leftventricle of the heart that lies beneath the coronary artery. A stent orconduit is positioned in the passage to keep it open, and allow for theflow of oxygenated blood directly from the heart into the coronaryartery. Again, it should be understood that while the insertion of theconduit in the myocardium between the left ventricle and the coronaryartery is described in detail below, this is merely exemplary and use ofthe conduit between other chambers of the heart and the coronary artery,and between blood vessels is also contemplated.

The principles of the present invention are not limited to leftventricular conduits, and include conduits for communicating bodilyfluids from any space within a patient to another space within apatient, including any mammal. Furthermore, such fluid communicationthrough the conduits is not limited to any particular direction of flowand can be antegrade or retrograde with respect to the normal flow offluid. Moreover, the conduits may communicate between a bodily space anda vessel or from one vessel to another vessel (such as an artery to avein or vice versa). Moreover, the conduits can reside in a singlebodily space so as to communicate fluids from one portion of the spaceto another. For example, the conduits can be used to achieve a bypasswithin a single vessel, such as communicating blood from a proximalportion of an occluded coronary artery to a more distal portion of thatsame coronary artery.

In addition, the conduits and related methods can preferably traversevarious intermediate destinations and are not limited to any particularflow sequence. For example, in one preferred embodiment of the presentinvention, the conduit communicates from the left ventricle, through themyocardium, into the pericardial space, and then into the coronaryartery. However, other preferred embodiments are disclosed, includingdirect transmyocardial communication from a left ventricle, through themyocardium and into the coronary artery. Thus, as emphasized above, theterm “transmyocardial” should not be narrowly construed in connectionwith the preferred fluid communication conduits, and othernon-myocardial and even non-cardiac fluid communication are preferred aswell. With respect to the walls of the heart (and more specifically theterm “heart wall”), the preferred conduits and related methods arecapable of fluid communication through all such walls including, withoutlimitation, the pericardium, epicardium, myocardium, endocardium,septum, etc.

The bypass which is achieved with certain preferred embodiments andrelated methods is not limited to a complete bypass of bodily fluidflow, but can also include a partial bypass which advantageouslysupplements the normal bodily blood flow. Moreover, the occlusions whichare bypassed may be of a partial or complete nature, and therefore theterminology “bypass” or “occlusion” should not be construed to belimited to a complete bypass or a complete occlusion but can includepartial bypass and partial occlusion as described.

The preferred conduits and related methods disclosed herein can alsoprovide complete passages or partial passages through bodily tissues. Inthis regard, the conduits can comprise stents, shunts, or the like, andtherefore provide a passageway or opening for bodily fluid such asblood. Moreover, the conduits are not necessarily stented or lined witha device but can comprise mere tunnels or openings formed in the tissuesof the patient.

The conduits of the present invention preferably comprise both integralor one-piece conduits as well as plural sections joined together to forma continuous conduit. The present conduits can be deployed in a varietyof methods consistent with sound medical practice including vascular orsurgical deliveries, including minimally invasive techniques. Forexample, various preferred embodiments of delivery rods and associatedmethods may be used. In one embodiment, the delivery rod is solid andtrocar-like. It may be rigid or semi-rigid and capable of penetratingthe tissues of the patient and thereby form the conduit, in whole or inpart, for purposes of fluid communication. In other preferredembodiments, the delivery rods may be hollow so as to form the conduitsthemselves (e.g., the conduits are preferably self-implanting orself-inserting) or have a conduit mounted thereon (e.g., the deliveryrod is preferably withdrawn leaving the conduit installed). Thus, thepreferred conduit device and method for installation is preferablydetermined by appropriate patient indications in accordance with soundmedical practices.

In some individuals, aortic insufficiency or peripheral venousinsufficiency occurs. Aortic insufficiency is the leakage of bloodthrough the aortic valve, resulting in a backflow of blood into the leftventricle. The heart compensates for the backflow of blood by pumpingharder, resulting in hypertrophy (thickening of the heart muscle) anddilation of the left ventricle wall. Left untreated, heart failure canresult. In venous insufficiency, the heart valves are unable to preventthe backflow of blood. This too can result in heart failure.Accordingly, one embodiment of the invention provides for the use of aconduit placed within the heart wall to improve the flow of oxygenatedblood through the body.

A first embodiment of the present invention is illustrated in FIG. 1B.This embodiment is a balloon-expanded stent 10. The stent 10 isintroduced as described below, using a high-pressure balloon catheter 12to deploy the stent 10 once it is properly positioned in the myocardiumMYO (FIG. 2). When the stent 10 is positioned inside the myocardial wallMYO, the balloon 14 is inflated to expand the stent 10 and open theconduit from the left ventricle LV into the coronary artery CA. Thestent 10 can include attachment mechanisms not limited to hooks, barbs,flanges, large collars, suture holes and/or other means to ensure a sealis created between the coronary artery CA and the wall of the myocardiumMYO and to prevent the threat of stent 10 migration. When the attachmentof the stent 10 is completed, the remaining catheter assembly 12 isremoved, leaving the stent 10 in place. Upon deflating the balloon 14,the stent 10 will remain open. Because of the shape of this stent 10, adumbbell shaped balloon 14 is preferably used to ensure properexpansion, as described below.

FIGS. 1B through 4 illustrate the introduction of the balloon-expandedstent 10 into the myocardial wall MYO. FIG. 1B illustrates the stent 10mounted over the balloon 14 on the distal end of the stent introducercatheter 12. FIG. 2 illustrates the stent introducer catheter 12following the path created by a puncture wire 16 extending past thedistal end of the introducer catheter 12, and used to access the leftventricle LV through the coronary artery CA and myocardium MYO. Furtherdetails regarding conduits and conduit delivery systems are described incopending patent applications entitled DELIVERY METHODS FOR LEFTVENTRICULAR CONDUIT, U.S. patent application Ser. No. 09/368,868, nowU.S. Pat. No. 6,261,304, LEFT VENTRICULAR CONDUIT WITH BLOOD VESSELGRAFT, U.S. patent application Ser. No. 09/369,061, now U.S. Pat. No.6,254,564, VALVE DESIGNS FOR LEFT VENTRICULAR CONDUIT, U.S. patentapplication Ser. No. 09/368,393, now U.S. Pat. No. 6,641,610, LEFTVENTRICULAR CONDUITS TO CORONARY ARTERIES AND METHODS FOR CORONARYBYPASS, U.S. patent application Ser. No. 09/369,039, now abandoned, andBLOOD FLOW CONDUIT DELIVERY SYSTEM AND METHOD OF USE, U.S. patentapplication Ser. No. 09/368,644, now U.S. Pat. No. 6,302,892, all filedon Aug. 4, 1999, and U.S. Pat. Nos. 5,429,144 and 5,662,124, thedisclosures of which are all hereby incorporated by reference in theirentirety.

FIG. 3 illustrates the non-expanded stent 10 positioned inside themyocardial wall MYO prior to inflation of the balloon 14. FIG. 4illustrates an expanded stent 10 in position, with the introducercatheter 12 removed. Because of the way the attachment mechanisms 18expand on this stent 10, a dumbbell shaped balloon 14 is preferably usedto flare out the ends of the stent 10. These flared edges 18 maintainthe stent 10 in its proper position in the heart wall MYO and provide aseal between the coronary artery CA and the outer heart wall MYO.

The second embodiment of the stent or conduit incorporates aself-expanding stent 20, illustrated in FIGS. 5-8. The stent 20, havinga retaining sheath 26 to hold it in a non-expanded configuration, isintroduced into the wall of the myocardium MYO as follows. The stentdelivery catheter 22 is advanced over a puncture mechanism 24 and intothe wall of the myocardium MYO as described above. When the stent 20 isproperly seated in the myocardial wall MYO, its retaining sheath 26 iswithdrawn, allowing the stent 20 to expand and open a conduit from theventricle LV to the coronary artery CA. This stent 20 also includesattachment mechanisms not limited to hooks, barbs, flanges, largecollars, suture holes and/or other means to ensure a seal is createdbetween the artery CA and the wall of the myocardium MYO, and to preventthe threat of stent 20 migration. When the positioning is completed, theremaining catheter assembly 22 is removed, leaving the stent 20 inplace.

The self-expanding stent 20 mounted on the distal end of the stentintroducer catheter 22 is illustrated in FIG. 5. FIG. 6 illustrates thestent introducer 22 following the path created by a puncture wire 24used to form the passage between the coronary artery CA and the leftventricle LV. FIG. 7 illustrates a non-expanded stent 20 located inposition on the stent introducer catheter 22 with the introducercatheter 22 in position in the heart wall MYO. FIG. 8 illustrates theself-expanding stent 20 in position, with the introducing catheter 22removed. Flared edges 28 on the stent 20 maintain its proper position inthe heart wall MYO and provide a seal between the coronary vessel CA andouter surface of the heart MYO.

For the stent designs described above, additional anchoring methods maybe desired to maintain the stent's proper position and/or create aleak-free seal in the coronary artery. Suitable attachment mechanismsinclude a set of barbs located on the stent body or flares and a collaron the coronary side to help seal and prevent blood from exiting the gapbetween the vessel and outer heart wall. The stent can also be anchoredin place by applying sutures. The stent can include holes at either endto facilitate the placement of these anchoring sutures. A suture gun canbe used to apply multiple sutures at the same time. In addition, thestents can be lined, if desired, with materials such as polymers, forexample polytetrafluoroethylene (PTFE), silicone or GORTEX, to providefor the ease of blood flow therethrough.

A third embodiment of the stent design, illustrated in FIGS. 9-11,incorporates attachment flanges or “legs” 30 that expand afterintroduction into the myocardium to hold the stent 34 in place. Thepuncture instrument 32 and stent 34 are mated together and are advancedinto the myocardial wall as a single unit. The puncture instrument'sdistal end 36 is shaped in a “nose-cone” configuration, which isresponsible for containing the legs 30 of the stent 34 while it is beingintroduced into the wall of the myocardium. When the stent 34 is in theproper position in the myocardial wall, the nose cone 36 is pushedforward, releasing the attachment legs 30 of the stent 34. The internaldiameter (ID) of the stent 34 is large enough to allow the nose cone 36to pass back through. The stent 34 is then released from the catheter 38and the catheter 38 is removed.

FIG. 9 illustrates the stent 34 mounted on the introducer catheter 38.The expanding legs 30 of the stent 34 are held in place by the nose cone36 on the distal end of the catheter 38 that acts as a dilator. Thecatheter assembly 38 is advanced over a puncture wire if desired, intoproper position in the myocardium, and the nose cone 36 is pushedforward allowing the legs 30 to expand as shown in FIG. 10. Thenosecone/puncture assembly 32, 36 is then withdrawn through the lumen ofthe stent 34. When the nose-cone/puncture assembly 32, 36 is removed,the stent 34 can be pushed off the introducer catheter 38 and remains inthe myocardium in the position shown in FIG. 11. FIG. 11 alsoillustrates a sealing collar 44 that may be used in the interfacebetween the coronary artery and the outer wall of the heart to preventhemorrhaging around the stent 34 and to hold the stent 34 in place.Sutures can be used to ensure that the stent is maintained in its properposition and prevent migration.

FIG. 12 illustrates a further embodiment of the present invention, a“bulkhead” stent 50. This stent 50 consists of a plurality of rings,which are placed in the myocardium MYO. The rings 50 form a passagethrough which blood flows from a chamber in the heart, such as the leftventricle LV, directly into the coronary artery CA. The stent 50 ispreferably formed of biocompatible material such as a metal or polymer.A gun or other suitable device can be used to implant the stent 50 inthe myocardium MYO.

If desired, the separate units or rings of the stent 50 can be connectedvia a wire, suture thread, or similar means. The wire is threadedthrough the holes 51 located in each ring. Connecting the rings of thestent 50 in this manner serves to make the stent 50 more stable and toprevent the migration of the individual units. If desired, a valve (notshown) can be incorporated into the stent 50 to help prevent thebackflow of blood into the left ventricle LV. Additional detailsregarding valve designs are disclosed in the above referenced copendingapplications entitled LEFT VENTRICULAR CONDUIT WITH BLOOD VESSEL GRAFT,U.S. patent application Ser. No. 09/369,061, now U.S. Pat. No.6,254,564, VALVE DESIGNS FOR LEFT VENTRICULAR CONDUIT, U.S. patentapplication Ser. No. 09/368,393, now U.S. Pat. No. 6,641,610 and LEFTVENTRICULAR CONDUITS TO CORONARY ARTERIES AND METHODS FOR CORONARYBYPASS, U.S. patent application Ser. No. 09/369,039, now abandoned,filed on Aug. 4, 1999, all of which are incorporated by reference intheir entirety.

If desired, the stent or conduit of the present invention can be formedof biodegradable or bioabsorbable materials and/or used to deliver drugsdirectly into the myocardium and the coronary circulation. Such a stent52 is illustrated in FIG. 13. The biodegradable stent 52 can extend onlypartially through the myocardium MYO as illustrated in FIG. 13, but canalso extend entirely through from the left ventricle LV to the coronaryartery CA. Once positioned in the myocardium MYO, the stent 52 degrades,dissolves or is absorbed over time to release drugs, genes, angiogenesisor growth factors, or other pharmaceutical compounds directly into theheart muscle MYO and the coronary artery CA, as shown by the arrows inFIG. 13. Bioabsorbable materials include, but are not limited to,polymers of the linear aliphatic polyester and glycolide families, suchas polylactide and polyglycolide. Further details are described in theabove-referenced application entitled LEFT VENTRICULAR CONDUITS TOCORONARY ARTERIES AND METHODS FOR CORONARY BYPASS, U.S. patentapplication Ser. No. 09/369,039, now abandoned, filed on Aug. 4, 1999.

Turning now to FIGS. 14-26, there is illustrated in greater detail onepreferred method and apparatus for providing a bulkhead stent 50, asshown in FIG. 12, into the myocardium MYO. As shown in FIG. 14, a stentdelivery catheter 60 is advanced over a puncture wire 62 and into thewall of the myocardium MYO as described above. The stent deliverycatheter 60 follows the path created by the puncture wire 62 used toform the passage between the coronary artery CA and the left ventricleLV. FIG. 15 illustrates a bulkhead stent 50 still located in positioninside the stent delivery catheter 60 with the catheter 60 in positionin the heart wall MYO. FIGS. 16-19 show one embodiment for deploying thebulkhead stent 50 into the myocardium MYO. As the delivery catheter 60is retracted proximally from the myocardium MYO, the rings comprisingthe bulkhead stent 50 are deployed into the myocardium MYO. FIGS. 20 and21 are enlarged views of FIGS. 18 and 19, showing the rings of thebulkhead stent 50 positioned within the myocardium MYO to form thepassageway therethrough.

FIGS. 22-25 illustrate more particularly the structure and deployment ofthe rings comprising the bulkhead stent 50. As shown in FIG. 24, thebulkhead stent comprises a plurality of rings 64 that are initiallyloaded into the delivery catheter 60. While inside the lumen of thecatheter 60, each ring 64 has a loaded configuration 64A, shown in FIGS.22 and 25. After ejectment from the catheter 60, the ring 64 assumes aninserted configuration 64B, shown in FIGS. 23 and 25. Preferably, theinserted configuration of ring 64B includes a plurality of flanges 66around the circumference of each ring 64, thereby providing a securementmechanism to anchor each ring 64 to the myocardium MYO. Each ring 64transforms from its loaded configuration 64A to its insertedconfiguration 64B by virtue of being released from the catheter 60.Specifically, the catheter 60 acts as a restraint on each ring 64 tokeep it in its loaded configuration 64A. Then, once the ring 64 isreleased from the catheter 60, the flanges 66 provided along thecircumference of each ring 64 are allowed to extend outward to providethe securement mechanism.

FIG. 26 illustrates an inserter device or handle 68 that may be used indeploying the bulkhead stent 50 into the myocardium. The inserter handle68 preferably comprises a gun 70 with a trigger 72, and a wire 74extending from a nozzle 76. The rings 64 (not shown) of the bulkheadstent 50 are preferably loaded onto the wire 74, and may be deployedinto the myocardium preferably one at a time by pressing the trigger 72.

FIGS. 27-30 illustrate another embodiment of the present invention.Here, a self-expanding spring or screw stent 140 is delivered into themyocardium MYO. As illustrated in FIG. 27A, a channel 142 through thewall of the myocardium MYO is first created, as described above, using adevice 144 delivered through the aorta AO and coronary artery CA. Thechannel 142 travels from the coronary artery CA through the myocardiumMYO and into the left ventricle LV as shown in FIG. 27B. The distal endof the stent delivery catheter 146 bearing the stent 140 is thenpositioned within the channel 142, as shown in FIG. 28. Preferably, theposition of the distal end of the delivery catheter 146 is checkedradiographically, to ensure proper positioning. Next, as illustrated inFIG. 29, the self-expanding spring stent 140 is delivered into thechannel 142 wall of the myocardium MYO. The stent 140 is cut such thatit does not extend past the myocardium MYO and into either the leftventricle LV or the coronary artery CA. Again, the proper positioningand length of the stent 140 is preferably checked radiographically andany necessary adjustments made before the delivery catheter 146 isremoved, as shown in FIG. 30.

FIG. 31 illustrates another embodiment of the stent 200 having retentionmembers 202. The hollow stent body 204 is held in place in the heartwall by one or more retention members 202 which are deployed after thestent 200 is properly positioned, as described above. FIG. 31 shows theretention members 202 in their deployed position. A flange 206 acts toseal the opening in the coronary artery, while the retention members 202reside in the myocardium, helping to anchor the stent 200 in place.

It should be appreciated that the stents described above, andparticularly the bulkhead stent, are useful in other applications inaddition to stenting the myocardium. For example, these stents may alsoserve as other types of coronary stents, arterial or venous stents, aswell as billiary and esophageal stents.

The present vascular shunt provides significant improvements in thepresent treatment of blockages in the coronary artery. Although theinvention has been described in its preferred embodiments in connectionwith the particular figures, it is not intended that this descriptionshould be limited in any way.

1-13. (canceled)
 14. A tissue implant device for implantation intoischemic tissue comprising: an implant having a first configuration witha first profile and a second configuration having a second profile thatis greater than the first profile whereby surrounding tissue into whichthe implant is placed in stress and is irritated sufficiently to causean injury response including thrombosis formation that initiatesangiogenesis; the implant comprising a plurality of expandable memberseach having a free end and an end joined to the implant, each memberconfigured to diverge away from a substantially common centrallongitudinal axis of the implant during self-expansion from the firstconfiguration to the second configuration.
 15. An implant as defined inclaim 14 further comprising a flare that is resiliently expandable fromthe first configuration to the second configuration.
 16. An implantdevice as defined in claim 14 wherein the implant defines a hollowinterior.
 17. An implant device as defined in claim 14 wherein theimplant is flexible after assuming the second configuration.
 18. Animplant device as defined in claim 14 wherein the implant defines atrunk portion aligned along the longitudinal axis of the implant anddefining expandable members that are legs extending from the trunkportion and that diverge away from the longitudinal axis upon expansion.19. An implant device as defined in claim 14 wherein a first portion ofthe body aligned along the longitudinal axis of the implant remainsstatic during and after delivery and a second portion of the body isdefined by expandable members that move to a different position relativeto the first portion after implantation to comprise a secondconfiguration of the device.
 20. An implant device as defined in claim19 wherein the implant comprises an elastic material and themotivational energy to cause the implant to move from the first to thesecond configuration is the inherent resiliency of the material.
 21. Atissue implant device for implantation into ischemic tissue comprising:an implant having a first configuration with a first profile and asecond configuration having a second profile that is greater than thefirst profile; the implant comprising a plurality of expandable memberseach having a free end and an end joined to the implant, each memberconfigured to diverge away from a substantially common centrallongitudinal axis of the implant during self-expansion from the firstconfiguration to the second configuration.
 22. An implant device asdefined in claim 21 further comprising a flare, a leg, a flange, a hook,a barb, or a collar that is resiliently expandable from the firstconfiguration to the second configuration.
 23. An implant device asdefined in claim 21 wherein the implant defines a hollow interior. 24.An implant device as defined in claim 21 wherein the implant is flexibleafter assuming the second configuration.
 25. An implant device asdefined in claim 21 wherein the implant defines a trunk portion alignedalong the longitudinal axis of the implant and defining expandablemembers that are legs extending from the trunk portion and that divergeaway from the longitudinal axis upon expansion.
 26. An implant device asdefined in claim 21 wherein a first portion of the body aligned alongthe longitudinal axis of the implant remains static during and afterdelivery and a second portion of the body is defined by expandablemembers that move to a different position relative to the first portionafter implantation to comprise a second configuration of the device. 27.An implant device as defined in claim 26 wherein the implant comprisesan elastic material and the motivational energy to cause the implant tomove from the first to the second configuration is the inherentresiliency of the material.
 28. A method for placing a conduit in thewall of a patient's heart to establish a blood flow path between acoronary vessel and a heart chamber, the method comprising steps of: (a)positioning a guide member that extends through the coronary vessel andthe heart wall into a heart chamber; (b) using the guide member todeliver a conduit into the heart chamber; and (c) positioning theconduit in the heart wall to establish a blood flow path between theheart chamber and the interior of the vessel; wherein the conduit iscovered by a sheath, and further comprising covering at least a portionof the conduit while placing the conduit in the heart wall and thenremoving the sheath.